Manager, Regulatory Affairs

Job TitleMake sure to apply with all the requested information, as laid out in the job overview below.Regulatory Affairs ManagerDepartmentRegulatory AffairsLocationDelta Park Segensworth (Moving to Nursling Southampton in May 2026) / HybridGLSM03Working Hours37.5 Hours WeeklyOverviewCooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. Its more than making contact lenses – it about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures for our people and those who wear our contact lenses.Job Summary & What to ExpectAs the Regulatory Affairs Manager of our Regulatory Affairs team you will lead a team of specialists to ensure compliance with EU MDR and global regulatory requirements. You’ll play a key role in protecting and growing the business by providing expert regulatory guidance, managing technical documentation and supporting product registrations across multiple regions.Key ResponsibilitiesLead and manage a team of Regulatory Affairs Specialists fostering a high-performance culture.Maintain up-to-date knowledge of regional and national regulations and communicate changes to stakeholders.Author and compile Technical Files for CE approval and coordinate responses to Notified Body requests.Represent Regulatory Affairs in cross‑functional teams and technical audits across UK EU ACE and MENA regions.Review and approve product labelling and liaise with Competent Authorities and Ministries of Health.Provide input to Regulatory Affairs Impact Documents (RAIDs) and support CE marking and regional registrations.Independently manage multiple projects, department initiatives and day‑to‑day tasks.About YouWe are looking for someone who is a confident leader, highly organised and detail‑oriented. You’ll thrive in cross‑functional environments and be comfortable navigating complex regulatory landscapes. Your ability to influence, educate and drive projects to completion will be key to your success.Required Experience & EducationBachelor’s degree in a scientific or technical discipline.8–10 years of medical device regulatory experience.Strong working knowledge of MDD and MDR.Experience in technical writing and evaluating manufacturing changes for regulatory impact.PreferredExperience with electronic document management systems.Strong IT analytical and communication skills.Ability to work effectively in multinational / multicultural environments.Key SkillsProofreading, Adobe Acrobat, FDA Regulations, Manufacturing & Controls, Biotechnology, Clinical Trials, Research & Development, GLP, cGMP, Product Development, Chemistry, Writing Skills.BenefitsCompetitive compensation and bonus.Private medical insurance.25 days holiday.Pension scheme.Healthcare cover and life assurance.Access to our Wellness Platform to support your mental health and wellbeing.Discounted contact lens scheme.Extensive training and career development.LinkedIn Learning access.Employee referral scheme (100 voucher reward).What You Can ExpectAs a CooperVision employee you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride African Descent Women Impact Network and Mind Body and Wellbeing Employee Resource Groups we offer opportunities for employees to learn and grow within an inclusive and safe space.Equal Opportunity StatementAll suitably qualified applicants will receive equal consideration and opportunities from CooperVision.How to ApplyApply today xpwpeyx For more information, view all opportunities on our careers page.Employment TypeFull‑TimeFunctional AreaRegulatory AffairsExperience Required8–10 years#J-18808-Ljbffr